ES2389727T3 - Oatmeal food products and compositions - Google Patents

Abstract

A therapeutic composition for oral use comprising at least 25% dry weight of protein and at least 1% dry weight of emulsifying lipids, obtaining both protein and emulsifying lipids from the same oat fraction, and the ratio in Protein weight with respect to emulsifying lipids is from 1: 0.01 to 1: 0.6, said b-glucan composition further comprising an amount of at most 8% dry weight, and in which the emulsifying lipids comprise phospholipids and glycolipids and the weight ratio of phospholipids to glycolipids is from 1: 0.7 to 1: 6.

Description

Oatmeal food products and compositions

The present invention relates to the field of food and nutrition, especially functional foods. The new products refer to therapeutic compositions and food products prepared from oat fractions. The compositions are suitable for improving the serum lipid profile. The invention also relates to methods for preparing the compositions.

Background of the invention

Cardiovascular disease (CVD) is one of the leading causes of death in the western world. The elevated serum levels of triacylglycerol and LDL (low density lipoprotein) -cholesterol and / or total cholesterol, as well as a low ratio of HDL (high density lipoprotein) -cholesterol compared to LDL-cholesterol, are some

15 of the main risk factors for CVD. Recently it has also been shown that serum levels of apolipoprotein B 100 (apo B) are a reliable marker of CVD risk. One of the first stages in the improvement of the serum lipid profile is changes in lifestyle including changes in diet and exercise. However, it seems difficult to change dietary habits and follow dietary recommendations. Therefore, there is a clear need for solutions beyond the regular diet and lifestyle changes through which the serum lipid profile can be improved.

Food products enriched with components that have a hypocholesterolemic effect beyond normal nutrition have been commercially available for some time. Representative examples of the components are soy protein and plant sterols, especially esters of sterile fatty acids or

25 plant stanols. The esters of stannel fatty acids and the hypocholesterolemic effects thereof are disclosed in US Pat. No. 5,502,045 as well as a suitable method for its preparation. It is reported that dietary intake of 2 to 3 g / day of plant stanols decreases serum levels of LDLcolesterol in man up to 14% without affecting HDL-cholesterol levels. The FDA has also approved a health claim on the role of soy protein in reducing the risk of CVD by lowering blood cholesterol levels.

It is also known that soy protein hydrolyzate lowers serum cholesterol (JP 60011425). The hypocholesterolemic effect of soy protein hydrolyzate could be attributed to certain peptides. Hypocholesterolemic peptides have also been found from bovine milk β-lactoglobulin (Nagaoka

35 et al., Biochem. Biophys Res. Commun., 2001, 281 (1), 11-17), but its efficacy has not yet been demonstrated by well-controlled clinical studies.

EP 0790060 discloses a protein / phospholipid hydrolyzate complex to improve lipid metabolism, the complex containing 10% or more of bound phospholipids, especially enzymatically modified lecithin or lecithin. EP 0790060 also discloses a process for preparing the protein / phospholipid hydrolyzate complex comprising mixing a protein hydrolyzate with phospholipids and recovering the complex formed. Another method disclosed in EP 0790060 for preparing the protein / phospholipid hydrolyzate complex comprises mixing the protein with a phospholipid to form a complex, hydrolyzing the complex protein in an aqueous medium and recovering the hydrolyzate complex from

45 proteins / phospholipids formed.

It is also known that oat bran and oatmeal have beneficial effects on serum cholesterol levels. The beneficial effect is attributed to soluble fiber β-glucan. For example, JP 1196270 describes the processing of oat bran to increase the soluble fiber content and, when increasing it, obtain a greater serum lipid enhancement activity. Β-Glucan extracts are prepared from corn flakes or other cereals such as barley. Normally, the other components of oats, such as protein or lipids, are not considered as valuable as β-glucan. The high lipid content of corn flakes has been a major drawback in finding food applications for oatmeal components, especially for oat protein. Oat fractions containing protein and lipids have been used

55 mainly in feed and cosmetics.

Hydrolysis, for example by enzymatic methods, has been used to obtain water soluble cereal proteins. WO 02/067698 uses enzymes that hydrolyze starch and phytate in combination with aqueous wet milling for fractionation of cereal bran components. The bran is processed to obtain protein fractions derived substantially from the germ, residual endosperm or aleurone cells. Also described is a protein hydrolyzate produced by incorporating proteases in the aforementioned protein fractions in the wet state, under controlled conditions of temperature and pH. Protein hydrolyzate has enhanced functionalities such as solubility, emulsification and foaming capabilities. These hydrolysates and protein fractions contain high amounts of dietary fiber

65 soluble.

EP 0619950 describes a process for preparing a stable, low-fat, water-soluble oat protein fraction. The oatmeal material is treated with protease outside the isoelectric range of the protein, preferably under alkaline conditions and insoluble fractions are separated, ie the insoluble solid fraction and the insoluble liquid fraction that is mainly oat fat, and the fraction is recovered. from

5 soluble oat protein. Protease treatment dissociates oat fat and soluble oat peptides. The small amount of oat fat that remains in the protein fraction after alkaline treatment consists of free fatty acids. Therefore, the protein fraction obtained does not contain emulsifying lipids. No therapeutic effects are attributed to these hydrolysates of water soluble cereal proteins.

US 4,282,319 discloses a process for the in situ preparation of enzymatically hydrolyzed starch and protein products from the whole cereal. First, the cereal material, such as wheat, barley or oats, is subjected to an endopeptidase treatment in aqueous medium so that substantially all water insoluble proteins present in the cereal are transformed into water soluble protein products, which are then filtered and recovered as a transparent filtrate. Therapeutic effects and / or are not attributed

15 on the health of these water soluble cereal protein hydrolysates.

US 2003/068357 A1 discloses a food product for lowering serum cholesterol levels, the active components being a soluble fiber and a sterol or a fatty acid derivative thereof. The soluble fiber may be psyllium, oatmeal, oat bran, barley, beta-glucan, guar gum, beet pulp or pectin and the amount thereof is preferably between 1 and 25 percent by weight. Exemplary compositions also include protein.

Önning G. et al. "Consumption of oat Milk for 5 Weeks Lowers Serum Cholesterol and LDL Cholesterol in Free-Living Men with Moderate Hypercholesterolemia", Annals of Nutrition and Metabolism, vol. 43, 2000, pages 301-309,

25 addresses a study aimed at investigating whether the consumption of an oat milk lacking insoluble fiber would result in lower levels of LDL-cholesterol and serum cholesterol in men. The oat milk tested was prepared from commercial oat flakes and a thermally treated dry ground oat bran fraction, and in the manufacturing process insoluble fibers were separated.

A combination of emulsifying proteins and lipids from an oatmeal fraction as such or additionally treated with protease has not been associated with prophylactic and / or health effects, particularly without an effect of improving the serum lipid profile. The present invention provides new therapeutic compositions to improve the serum lipid profile, that is, to lower levels of LDL-cholesterol and / or total cholesterol and / or decrease levels of apolipoprotein B and / or decrease levels of triglycerides and / or increase the level of HDL

35 cholesterol and / or increase the ratio of HDL levels with respect to LDL-cholesterol.

Summary of the invention

The present invention provides a therapeutic composition for oral use comprising an oatmeal fraction comprising naturally occurring protein and emulsifying lipids. The therapeutic composition is prepared from an oatmeal starting material that contains both naturally occurring protein and emulsifying lipids. The composition contains at least 25% dry weight of proteins and at least 1% dry weight of emulsifying lipids.

The present invention also provides an oat-based therapeutic composition for oral use comprising naturally occurring protein hydrolyzate (s) and emulsifying lipids that have been prepared by hydrolyzing an oat-based starting material that has both proteins as emulsifying lipids that occur naturally, preferably enzymatically with protease. The amount of protein hydrolyzate is at least 15% dry weight and the amount of emulsifying lipids at least 1% dry weight in the therapeutic composition. In a preferred embodiment, the composition is prepared from an oatmeal fraction that has an increased protein content.

It has been found that oat-based compositions comprising naturally occurring emulsifying protein and lipid hydrolysates can be used therapeutically, especially for an effect of

55 improvement of the serum lipid profile. The oat-based compositions comprising protein hydrolysates and emulsifying lipids of this invention were compared with a commercial soybean protein-phospholipid hydrolyzate complex and were surprisingly found to work similarly or even better in the test. In addition, compositions comprising both protein and emulsifying lipids of the present invention functioned correspondingly.

The present invention preferably uses oat-based fractions that are conventionally used primarily as raw materials for food for the preparation of therapeutic compositions. Another advantage with the use of corn flakes is that it is not allergenic compared to, for example, both soybeans and wheat.

The therapeutic compositions of the present invention can be used orally as such or as pharmaceutical or nutraceutical products or more advantageously in food products. Another object of the invention is to provide a food product comprising the therapeutic compositions. Food products are preferably used to improve the serum lipid profile.

The invention also provides a method for preparing therapeutic compositions using a material of

A heading that naturally comprises both a protein and emulsifying lipids. The method of preparing the compositions comprising protein hydrolysates includes hydrolysis of the protein. Emulsifying lipids remain with the resulting protein hydrolyzate fraction. The therapeutic composition obtained contains at least 15% by weight of protein hydrolyzate and at least 1% by weight of emulsifying lipids. The advantages of this method are a simplified and more cost effective preparation of therapeutic compositions comprising protein hydrolysates and emulsifying lipids. No individual steps are necessary to first separate and purify the protein and the lipid fractions, and then prepare the protein hydrolyzate and thereafter combine the protein hydrolyzate and the lipid fraction.

One of the objectives of the present invention is to provide a therapeutic composition for oral use obtained at

Starting from oat fractions comprising protein and emulsifying lipids to improve the serum lipid profile in humans and / or animals and a method to improve the serum lipid profile in humans and / or animals by oral administration of the composition. .

Another objective of the present invention is to provide oat-based therapeutic compositions containing hydrolyzate (s) of emulsifying proteins and lipids for oral use to improve the serum lipid profile in humans and / or animals and a method to improve the profile of serum lipids in humans and / or animals by oral administration of the composition.

The characteristic features of the present invention are set forth in the claims. 25

Detailed description of the invention

An aspect of the present invention is a therapeutic composition for oral use comprising at least 25% dry weight of protein and at least 1% dry weight of emulsifying lipids, both protein and emulsifying lipids being obtained from the same fraction of oatmeal. The weight ratio of protein to emulsifying lipids is from 1: 0.01 to 1: 0.6 in the therapeutic composition. The composition further comprises β-glucan in an amount of at most 8% dry weight. Emulsifying lipids comprise phospholipids and glycolipids and the weight ratio of phospholipids to glycolipids is from 1: 0.7 to 1: 6. The therapeutic composition is prepared from an oatmeal starting material that contains both

35 protein as emulsifying lipids that occur naturally. The therapeutic composition preferably comprises at least 30%, more preferably at least 35% and most preferably at least 40% dry protein weight, and preferably at least 2%, more preferably at least 2.5%. and most preferably at least 3% by dry weight of emulsifying lipids.

Another aspect of the present invention is a therapeutic composition for oral use comprising at least 15% dry weight of protein hydrolyzate and at least 1% dry weight of emulsifying lipids, both protein and emulsifying lipids being obtained from of the same oat fraction that has undergone hydrolysis, and the weight ratio of protein hydrolyzate with respect to emulsifying lipids is from 1: 0.01 to 1: 1. The composition further comprises β-glucan in an amount of at most 8% in

45 dry weight. Emulsifying lipids comprise phospholipids and glycolipids and the weight ratio of phospholipids to glycolipids is from 1: 0.7 to 1: 6.

The invention also relates to therapeutic compositions based on oatmeal for oral use comprising at least 15% dry weight of protein hydrolyzate (s) and at least 1% dry weight of emulsifying lipids, obtaining both protein and emulsifying lipids from the same oatmeal fraction that has undergone hydrolysis, preferably enzymatic hydrolysis using protease. The weight ratio of protein hydrolyzate with respect to emulsifying lipids is from 1: 0.01 to 1: 1. The composition further comprises βglucan in an amount of a maximum of 8% by dry weight. Emulsifying lipids comprise phospholipids and glycolipids and the weight ratio of phospholipids to glycolipids is from 1: 0.7 to 1: 6. In a

In the preferred embodiment, the compositions are prepared from oat fractions that have an increased protein content and that contain emulsifying lipids. The preparation method includes hydrolysis of the protein. Emulsifying lipids remain with the resulting protein hydrolyzate fraction.

As used herein, the term "starting material" refers to an oat-based material that naturally comprises both protein and emulsifying lipids and is used for the preparation of the compositions of the present invention. In addition, the term "oat fraction" is used for the starting material. The starting material contains at least 10% dry weight of protein and at least 1% dry weight of emulsifying lipids. The ratio of protein to emulsifying lipids in the starting material is preferably from 1: 0.01 to 1: 0.6. In a preferred embodiment, the starting materials are oat fractions 65 with an increased protein content and containing emulsifying lipids. In addition to protein and lipids that have emulsifying properties, the starting material may also contain other components,

such as other lipids, for example triglycerides, carbohydrates, such as fiber and starch, and various minor components. In another preferred embodiment, the ratio of protein to emulsifying lipids is from 1: 0.1 to 1: 0.6, preferably from 1: 0.15 to 1: 0.6. The compositions of the present invention are characterized in that both the protein and the emulsifying lipids are obtained therefrom.

5 oatmeal fraction.

A preferred starting material is an oat endosperm-rich fraction comprising at least 10%, preferably at least 20% by dry protein weight and at least 1%, preferably at least 2%, more preferably at least 3% dry weight emulsifying lipids. Preferably an oat endosperm-rich fraction with an increased protein content is used. Technically it is easier to increase the protein content of an endosperm-rich fraction than, for example, of fractions that have a higher cell wall polysaccharide content, such as oat bran. An oat endosperm-rich fraction is especially suitable for the preparation of compositions containing protein hydrolyzate and emulsifying lipids because it is technically easier to produce these compositions from the fraction rich in

Oat endosperm which, for example, from fractions such as oat bran that have a higher content of cell wall polysaccharides, such as cellulose. The oat endosperm-rich fraction is often used as a raw material for food. Therefore, the production of the therapeutic compositions of this invention also provides a new, more effective use for this fraction.

Another preferred starting material is a whole grain based oat fraction comprising at least 10%, preferably at least 20% by dry protein weight and at least 1%, preferably at least 2%, more preferably at minus 3% dry weight of emulsifying lipids. Preferably a whole grain based oat fraction with an increased protein content is used. Technically it is easier to increase the protein content of a whole grain-based oatmeal fraction than. for example. of fractions that have

25 a higher content of cell wall polysaccharides, such as oat bran. The use of a whole grain fraction as a starting material is also especially beneficial in a plant when oat fractionation is not available or fractional raw material is not available.

Another preferred starting material is an oat bran rich fraction comprising at least 10%, preferably at least 20% by dry protein weight and at least 1%, preferably at least 2%, more preferably at least 3% dry weight emulsifying lipids. Preferably a fraction rich in oat bran with an increased protein content is used. A fraction rich in oat bran is suitable for the preparation of compositions containing protein hydrolyzate and emulsifying lipids because it has the highest lipid and protein content of all commercially produced oat fractions.

The starting material can be used for the preparation of therapeutic compositions comprising protein or protein hydrolysates and emulsifying lipids that occur naturally or as such or further processed. Typical examples of starting materials include whole grain oatmeal, oat fractions such as endosperm-rich flour or bran-rich flour, and especially oat fractions with an increased protein content, which means that the protein content it is higher than the natural protein content in the part of the oats from which the material is obtained. The protein content can be increased by, for example, at least 30%, preferably at least 50%, more preferably at least 80% of the natural protein content. For example, the protein content of oat endosperm flour, obtained by conventional grinding techniques, is naturally of

45 approximately 11% by weight. This flour can be treated, for example enzymatically or by other means to increase the protein content in the oat fraction to be used as the starting material. The increased protein content can be obtained, for example, by removing part of the starch and / or other carbohydrates from the oat fraction to be used as the starting material.

As used herein, "emulsifying lipids" refers to lipid substances that occur naturally in the starting material and that promote the formation and improvement of emulsion stability. The characteristic feature of emulsifying lipids is a structure in which one part of the molecule is polar (hydrophilic) and the other apolar (hydrophobic), allowing the emulsifying lipid to align and stabilize the contact surfaces of the two immiscible phases. of the emulsion. Having the right amount of lipids

Emulsifiers in the compositions of the present invention enhance the therapeutic effect of the compositions and guarantee the optimum availability of the components at the site of action and is therefore an essential feature of the invention. Emulsifying lipids also facilitate the incorporation of the compositions into food products. By using a starting material that naturally contains emulsifying lipids, there is no need to add emulsifiers from an individual source in compositions of the present invention. Oatmeal lipids, ie polar lipid fractions of oats, containing phospholipids and glycolipids are excellent for the purpose of this invention. In the composition of the invention, the emulsifying lipids comprise phospholipids and glycolipids, the weight ratio of phospholipids to glycolipids is from 1: 0.7 to 1: 6, preferably from 1: 1 to 1: 5 and more preferably from 1: 1 to 1: 3.

In addition to the emulsifying proteins and lipids, the starting material comprises other grain-based materials such as other lipids, carbohydrates and various minor components.

As used herein, the term "protein hydrolyzate" means all protein hydrolyzed products prepared using a proteolytic enzyme preparation, a microorganism that contains adequate proteolytic activity or acid hydrolysis or any combination thereof, and what does he have

5 therapeutic effect.

Preferred protein hydrolysates have a molecular weight of 300-1000 D, more preferably 500

50,000 D, even more preferably 500-30,000 D, even more preferably 900-30,000 D, and most preferably 1600-30,000 D and / or are not soluble or only slightly soluble in water (at most 20% by weight of the total protein hydrolyzate in water at 25 ° C under neutral pH conditions). A preferred protein hydrolyzate is the resistant protein, which is hydrolyzed so that no more than 60% by weight, preferably not more than 40%, of the resistant protein can be further digested in humans.

Compositions comprising protein hydrolysates are prepared from the starting material

15 hydrolyzing protein. Emulsifying lipids remain with the resulting protein hydrolyzate fraction. Thus, compositions comprising protein hydrolysates and emulsifying lipids are characterized in that both the protein and the emulsifying lipids are obtained from the same starting material, without first separating and then combining the protein and the emulsifying lipids.

The protein of the starting material is preferably hydrolyzed by enzymatic methods and methods well known in the art. Typical preparation methods include treating the material containing the protein and emulsifying lipids with a proteolytic enzyme in aqueous medium. The starting material is dispersed in water and the pH is adjusted with an acid or a base to the optimum pH range of the enzyme and the protein to be used. The enzyme is preferably added in an amount of 0.2-5%, more preferably 0.5-2% by weight

25 based on the substrate protein and the reaction is carried out at an optimum temperature and pH for the necessary time depending on the enzyme and the degree of hydrolysis desired. Normally, the degree of hydrolysis is from 1 to 40%, preferably from 3 to 30% and more preferably from 5 to 20% (analyzed as described by Nielsen et al., 2001, Journal of Food Science, vol. 66, No. 5). The reaction is usually terminated by heating the mixture to a temperature high enough to inactivate the enzyme. Inactivation can also be achieved by adjusting the pH. The reaction mixture can be optionally neutralized before or after the heating step using a suitable acid, for example hydrochloric acid, or a base, for example sodium hydroxide.

The composition can be used as such or the reaction mixture can be separated into based fractions, by

For example, in molecular weight or water solubility. Most preferably, the precipitate obtained is used, for example, by centrifugation or other corresponding separation techniques (a fraction insoluble in water or slightly soluble in water) or a fraction obtained by ultrafiltration. Most preferably, the precipitate is washed with water to remove water soluble components more efficiently. In addition, additional process steps may be included, such as further purification of certain peptide fractions or peptides and / or drying. For example, lyophilization, spray drying or any other drying process known in the art, which produces a powder either directly or through a crushing step, can be used.

Proteolytic enzymes that can be used in the preparation of the protein hydrolysates of the present

The invention includes enzymes of plant, microbial and animal origin, also including enzymes of genetically modified organisms and microorganisms that have proteolytic activity that under suitable reaction conditions hydrolyze proteins to give the therapeutic hydrolysates of this invention. Suitable proteolytic enzymes are, for example, pepsin, microbial aspartic proteases, trypsin, pancreatin, papain, subtilisin and other microbial serine proteases, thermolysin and bromelain. It is also possible to use different enzymes sequentially, for example pepsin and trypsin or pepsin and pancreatin. Especially preferred are enzymes or combinations of enzymes that produce protein hydrolysates that are only poorly digestible or are no longer digestible in the human intestine and are therefore also referred to as "resistant proteins" and that have the therapeutic effect of the present invention. Examples of these preferred enzymes especially include pepsin, trypsin and pancreatin.

A therapeutic composition according to the invention comprises at least 15%, preferably at least 20%, more preferably at least 30% by dry weight of protein hydrolyzate and at least 1%, preferably at least 2%, more preferably at least 3%, even more preferably at least 4%, even more preferably at least 5% and most preferably at least 6% by dry weight of emulsifying lipids, both the protein and the emulsifying lipids are obtained at from the same oat fraction that has been hydrolyzed, it has preferably been treated with protease, and the weight ratio of protein to emulsifying lipids is from 1: 0.01 to 1: 1.

In a preferred therapeutic composition comprising protein hydrolyzate and emulsifying lipids, the

The protein hydrolyzate content is from 15 to 99%, preferably from 20 to 98%, more preferably from 30 to 97%, most preferably from 30 to 94% by dry weight of the protein. Therapeutic composition and the content of emulsifying lipids is from 1 to 15%, preferably from 2 to 15%, more preferably from 2.5 to 15%, even more preferably from 3 to 15% , even more preferably from 4 to 15%, even more preferably from 5 to 15%, and most preferably from 6 to 15% by dry weight of the therapeutic composition. The reason for

Protein hydrolyzate with respect to emulsifying lipids is from 1: 0.01 to 1: 1, preferably from 1: 0.02 to 1: 0.5 and most preferably from 1: 0.03 to 1: 0 ,3. The rest of the composition, that is from 0 to 84%, preferably from 0 to 78%, more preferably from 0 to 67% and most preferably from 0 to 64% by dry weight, may comprise combination agents and / or grain-based materials such as carbohydrates, lipids other than emulsifying lipids and various minor components.

In another preferred therapeutic composition comprising protein hydrolyzate and emulsifying lipids, the protein hydrolyzate content is from 15 to 98%, preferably from 20 to 98%, more preferably from 30 to 97% and more preferably from 30 to 94% by dry weight of

The therapeutic composition and emulsifying lipid content is from 2 to 15%, preferably from 2 to 10%, more preferably from 2.5 to 10%, even more preferably from 3 to 8 %, even more preferably from 4 to 8%, even more preferably from 5 to 8% and most preferably from 6 to 8% by dry weight of the therapeutic composition. The ratio of protein hydrolyzate with respect to emulsifying lipids is from 1: 0.02 to 1: 1, preferably from 1: 0.02 to 1: 0.5 and most preferably from 1: 0.03 to 1: 0.3. The rest of the composition, that is from 0 to 84%, preferably from 0 to 78%, more preferably from 0 to 67% and most preferably from 0 to 64% by dry weight, may comprise combination agents and / or grain-based materials such as carbohydrates, lipids other than emulsifying lipids and various minor components.

In a preferred therapeutic composition comprising hydrolyzate of proteins and emulsifying lipids, the dietary fiber content is a maximum of 15%, preferably a maximum of 10%, more preferably a maximum of 5% and most preferably a maximum of 3% dry weight

In another preferred therapeutic composition comprising hydrolyzate of proteins and emulsifying lipids, the content of β-glucan is a maximum of 5%, preferably a maximum of 3% and more preferably a maximum of 2% by dry weight.

A therapeutic composition according to the invention comprises at least 25%, preferably at least 30%,

More preferably at least 35%, and most preferably at least 40% dry protein weight and at least 1%, preferably at least 2%, more preferably at least 3%, even more preferably at least 4%, even more preferably at least 5% and most preferably at least 6% dry weight of emulsifying lipids, and the weight ratio of protein to emulsifying lipids is from 1: 0.01 to 1 : 0.6.

In a preferred therapeutic composition comprising protein and emulsifying lipids, the protein content is from 25 to 99%, preferably from 30 to 98%, more preferably from 35 to 97.5%, even more preferably from 40 to 97% and most preferably from 40 to 94% by dry weight of the therapeutic composition and the content of emulsifying lipids is from 1 to 15%,

Preferably from 2 to 15%, more preferably from 2.5 to 15%, even more preferably from 3 to 15%, even more preferably from 4 to 15%, even more preferably from the 5 to 15% and most preferably from 6 to 15% by dry weight of the therapeutic composition. The ratio of the protein to emulsifying lipids is from 1: 0.01 to 1: 0.6, preferably from 1: 0.03 to 1: 0.6, more preferably from 1: 0.1 to 1 : 0.6, even more preferable from 1: 0.15 to 1: 0.6, and most preferably from 1: 0.15 to 1: 0.4. The rest of the composition, that is from 0 to 74%, preferably from 0 to 68%, more preferably from 0 to 62.5%, even more preferably from 0 to 57% and most preferably from 0 to 54% by dry weight, it may comprise combination agents and / or grain-based materials such as carbohydrates, lipids other than emulsifying lipids and various minor components.

In another preferred therapeutic composition comprising protein and emulsifying lipids, the protein content is from 25 to 98%, preferably from 30 to 98%, more preferably from 35 to 97.5%, even more preferably from 40 to 97% and most preferably from 40 to 94% by dry weight of the therapeutic composition and the content of emulsifying lipids is from 2 to 15%, preferably from 2 to 10 %, more preferably from 2.5 to 10%, even more preferably from 3 to 8%, even more preferably from 4 to 8%, even more preferably from 5 to 8% and most preferably from 6 to 8% by dry weight of the therapeutic composition. The ratio of the protein to emulsifying lipids is from 1: 0.02 to 1: 0.6, preferably from 1: 0.03 to 1: 0.6, more preferably from 1: 0.05 to 1 : 0.6 and most preferably from 1: 0.1 to 1: 0.4.

The rest of the composition, that is from 0 to 74%, preferably from 0 to 68%, more preferably from 0 to 62.5%, even more preferably from 0 to 57% and more preferably from 0 to 54% by dry weight, it may comprise combination agents and / or grain-based materials such as carbohydrates, lipids other than emulsifying lipids and various minor components.

5 In a preferred therapeutic composition comprising protein and emulsifying lipids, the dietary fiber content is a maximum of 15%, preferably a maximum of 10%, more preferably a maximum of 5% and most preferably a maximum of 3% by weight. dry.

In another preferred therapeutic composition comprising protein and emulsifying lipids, the content of βglucan is a maximum of 5%, preferably a maximum of 3% and more preferably a maximum of 2% by dry weight.

A preferred embodiment of the invention is the use of an oat endosperm-rich fraction as a source for protein hydrolyzate and emulsifying lipids, whereby it is obtained technically easily and

A functionally desirable therapeutic composition as disclosed in this specification is cost effective.

The therapeutic effects of the compositions of the present invention are directed to improve the serum lipid profile, especially in humans and / or animals. Therefore, in one aspect of the present invention, there is provided a method for improving the serum lipid profile, for example, for lowering LDL-cholesterol and / or total cholesterol and / or increasing HDL-cholesterol and / or reducing the triacylglycerol and / or reduce apolipoprotein B and / or increase the ratio of HDL-cholesterol with respect to LDL-cholesterol in a subject, which comprises administering orally to the subject a therapeutic composition according to the present invention in an amount effective to improve the serum lipid profile. In addition, the present invention provides a method to reduce or prevent the development of

Atherosclerosis in humans by dietary means including oral administration to the subject of a composition according to the present invention in an amount effective to improve the serum lipid profile.

The present invention also relates to guaranteeing the optimal availability of active components, especially hydrolyzed proteins, at the site of action. Compositions containing protein hydrolysates and emulsifying lipids according to the present invention are especially beneficial since the effect of improving the lipid profile is optimized by guaranteeing optimum availability of the active components.

In yet another aspect of the present invention, a combination of plant sterols and oat-based therapeutic compositions comprising protein hydrolyzate (s) and emulsifying lipids is provided.

35 that occur naturally. A combination of plant sterols and the therapeutic oat fraction comprising protein and naturally occurring emulsifying lipids are also provided. The weight ratio of vegetable sterol to protein hydrolyzate / protein is from 1: 0.02 to 1: 150, preferably from 1: 0.2 to 1:30, more preferably from 1: 0.4 to 1 : 12.5 and most preferably from 1: 1 to 1: 5 in therapeutic compositions. In addition, plant sterols improve the serum lipid profile, especially lower serum levels of LDL-cholesterol and total cholesterol, and surprisingly enhance the effects of improving the serum lipid profile of oat-based compositions of the present invention. Plant sterols are defined, for example, in WO 02/082929 and include desmethyl-sterols both unsaturated and saturated in their free form, esterified, for example, with fatty acids and mixtures thereof.

The composition of the present invention can be used as such or as a pharmaceutical product or a nutraceutical.

or in the most advantageous way in food products to improve the profile of serum lipids in man. The compositions may be added in any suitable manner to food, pharmaceutical or nutraceutical products. The incorporation of the compositions in food, pharmaceutical or nutraceutical products can be facilitated by reducing the particle size of said compositions, for example, by crushing, grinding or micromoldering. The active components are added in food material, pharmaceutical or nutraceutical products by conventional methods to produce these products.

In a further aspect of the present invention, a food product is provided comprising at least

A basic nutritional component and at least one of the therapeutic compositions of the present invention as defined above.

The food product of the present invention can be prepared by adding said composition to food material (s) by conventional methods for producing food products. The composition can be added, for example, as in liquid, semi-solid or dried form.

The food product of the present invention may be in the form of various food compositions, including but not limited to

65 - bakery products and confectionery products (fresh and dried bakery products, for example fresh bread, other bakery products, cakes, muffins, waffles, buns, crackers, cookies, protein-enriched bakery products, etc.)

-

 cereal products and snacks (breakfast cereals, muesli, bars, such as muesli and base bars

of cereals, possibly containing such chocolate bars, pasta products, flours, etc.) 5

-

 beverages (alcoholic and non-alcoholic beverages, including, for example, soft drinks, juices and mixed juices, fortified beverages such as, for example, beverages fortified with protein or calcium, probiotic beverages, energy and sports drinks, dietary supplement drinks and substitute foods, concentrates or premixes for beverages and powdered beverages in which the content of the compositions of the present invention is calculated for the ready-to-use form, etc.)

-

 dairy products (milk, milk-based products, for example cheese, cream cheese and the like, yogurt, frozen yogurt, other frozen dairy foods, drinking yogurt, other fermented milk products, dairy drinks, creams such as coffee cream, ice cream, desserts, spreads, etc.)

-

 fermented cereal products

-

 sauces, soups

-

 meat, fish, poultry and egg products (for example, sausages, meatballs, etc.)

-

 analogues for, for example, meat or dairy products (for example, imitations of cheese, yogurt, ice cream, desserts, meat substitutes, alternatives to milk, etc.), frozen non-dairy desserts

25 - soy products

-

 Vegetable oil based products (for example, margarines, spreads, dressings, mayonnaise, etc.)

-

 ready mixes (for baking, for example, breads, cakes, muffins, waffles, pizzas, crepes; or for cooking, for example, soups, sauces, desserts, puddings) for use in food preparation or preparation.

Solid or semi-solid food products are especially preferred. These products normally have a viscosity of at least 0.1 Pas, more usually at least 0.5 Pas measured by a Brookfield viscometer, at the conventional use temperature of the product in question.

The food product of the present invention may also contain other nutritionally beneficial components, some of which may further enhance the effects of the compositions of the present invention. The food can be enriched with these components or the components can be an intrinsic part of the other ingredients of the food.

Examples of the nutritionally beneficial components include plant sterols (as described above), diacylglycerol and n-3 fatty acids that also have advantageous effects on lipid metabolism and, therefore, can reduce the risk of cardiovascular disease. Other non-limiting examples of beneficial nutritional components include minority beneficial components, for example such as

45 isoflavones, tocopherols, tocotrienols, carotenoids, vitamin C, folate and flavonoids. In addition, other vitamins and minerals may be added or included in the food products of the present invention.

In a further aspect of the present invention, a pharmaceutical or nutraceutical product is provided to improve the serum lipid profile comprising a composition of the present invention as defined above. Said product may additionally contain at least one combination agent. The combination agent may be any pharmaceutically acceptable binder, carrier, diluent, excipient or coating agent. The product may be in any suitable form, for example tablets, granules, powder, capsules, syrups, dispersions or other liquid preparations for oral administration.

The present invention also relates to the use of a composition as defined above, that is, a therapeutic composition comprising protein and / or protein hydrolyzate and emulsifying lipids, both protein / protein hydrolyzate and emulsifying lipids being obtained. from the same oatmeal fraction for the manufacture of a pharmaceutical or nutraceutical or food product to improve the serum lipid profile.

When the therapeutic composition comprising hydrolyzate of proteins and emulsifying lipids according to the invention is added to a food product, the content in the composition is usually between 0.01-70 g per 100 g of food product, preferably 0.1- 60 g / 100 g, more preferably 0.5-50 g / 100 g, and most preferably 1.0-50 g / 100 g.

The optimal daily intake of therapeutic compositions comprising protein hydrolyzate and emulsifying lipids of the present invention as such or when added to food, nutraceutical or pharmaceutical products is such that a daily intake of protein hydrolyzate and emulsifying lipids is provided. 0.1-60 g, preferably 0.5-20 g, more preferably 0.8-10 g.

When the therapeutic composition comprising protein and emulsifying lipids according to the invention is added to

5 a food product, the content of the composition is usually between 0.01-70 g per 100 g of food product, preferably 0.1-60 g / 100 g, more preferably 1.0-50 g / 100 g, and most preferably 2.0-40 g / 100 g.

The optimal daily intake of therapeutic compositions comprising an oatmeal fraction comprising protein and emulsifying lipids of the present invention as such or when used in food, nutraceutical or pharmaceutical products is such that a daily intake of the protein and the ingredients is provided. emulsifying lipids of 0.5-100 g, preferably 1.5-75 g, more preferably 3.0-50 g.

The compositions according to the present invention are most preferably incorporated into foods designed to be part of a healthy diet.

The present invention also provides a method for preparing a therapeutic composition as defined above comprising at least 25% dry weight of protein and at least 1% dry weight of emulsifying lipids, said method comprising treating an oat fraction comprising both protein and emulsifying lipids and carbohydrates, such as starch, to remove carbohydrates, preferably by enzymatic hydrolysis, and to obtain said therapeutic composition having an increased protein content.

Additionally, the present invention provides a method for preparing a therapeutic composition such as

25 was defined above which comprises at least 15% dry weight of protein hydrolyzate and at least 1% dry weight of emulsifying lipids, said method comprising hydrolyzing an oat fraction comprising both protein and emulsifying lipids to obtain said composition therapy. The oatmeal fraction is preferably subjected to enzymatic hydrolysis, especially using protease. The degree of hydrolysis is preferably from 1 to 40%, more preferably from 3 to 30% and most preferably from 5 to 20%.

The invention is further illustrated by the following examples. In this specification, the percentages mean% by weight unless otherwise specified.

35 Example 1

An oat endosperm-rich fraction with an increased protein content was used as the starting material for the preparation of a composition containing protein hydrolysates and emulsifying lipids.

Flour rich in oat endosperm (bran removed by milling of whole grain oats), containing 12% protein and 7% lipids, 64% starch and 5% dietary fiber (Raisio) was suspended in water (1:10) and treated with α-amylase (Fungamyl 800L, Novozymes) at 65 ° C for 1 hour to reduce the starch content. The reaction mixture was further treated with cellulase and β-glucanase at 55 ° C (GC440, Genencor and Ultraflo L, Novozymes, 2% of the starting material) to hydrolyze the rest of the β-glucan, although most of the

Β-Glucan is soluble in water at 65 ° C and could have been removed from the insoluble fraction by, for example, centrifugation. Hydrolyzed starch and β-glucan products were removed from the precipitate by centrifugation. The resulting precipitate was lyophilized (= fraction rich in endosperm with an increased protein content) and contained 31% starch, 38% protein and 14% total lipids, including> 2% emulsifying lipids.

The dried endosperm-rich fraction was suspended in water (1:10), the pH was adjusted to 2 with hydrochloric acid and the protein was enzymatically hydrolyzed using pepsin (Sigma Aldrich, P7000, 1: 10,000 activity, 1% of the content in oatmeal protein). The reaction was carried out at 37 ° C for 24 hours and then the enzyme was quenched by heating the reaction mixture to 90 ° C for 30 min. The mixture was neutralized with

55 sodium hydroxide and centrifuged (4500 x g). The precipitate was washed twice with water after which the composition was lyophilized. The composition contained 20% protein hydrolyzate and 14% total lipids, including> 2% emulsifying lipids.

Example 2

Whole grain oatmeal material (average composition of 13% protein, 7% total lipids, 67% carbohydrates) was used as the starting material for the preparation of a composition containing protein and lipid hydrolyzate emulsifiers First, the whole grain starting material was enzymatically processed to decrease the amount of starch and fiber and to obtain a composition that had an increased 65 protein content and emulsifying lipids (27% protein, 9% lipids). in total, including> 2% of

emulsifying lipids and 52% carbohydrates). This oat fraction with an increased protein content was used for the preparation of the composition containing protein hydrolysates and emulsifying lipids.

The oat fraction was mixed in water (1:10) and hydrolyzed with pepsin at pH 2 as in Example 1 until

5 stage of inactivation. The pH of the reaction mixture was adjusted to 5 and the mixture was heated to 90 ° C to inactivate the pepsin and gelatinize the starch. During the inactivation step at 90 ° C, thermostable α-amylase (Spezyme FRED, Genencor, 1% of the starting material) was added to the reaction vessel to further reduce the starch content of the material. The α-amylase was allowed to react for 2 hours, after which the reaction mixture was cooled to 55 ° C and the pH was adjusted to 6. The fiber components were hydrolyzed by treating the

10 mixture with cellulase and β-glucanase at 55 ° C (GC440, Genencor and Ultraflo L, Novozymes, both 1% of the starting material) after which the mixture was centrifuged.

The precipitate was washed once with water, after which the composition containing protein hydrolyzate and emulsifying lipids was lyophilized. The composition contained 33% protein hydrolyzate, 14% lipids in

15 total, including> 3.0% emulsifying lipids.

Example 3

The oat fraction with an increased protein content of Example 5 (46% protein and 12% of

20 lipids, including> 3% emulsifying lipids) as a starting material for the preparation of a composition containing protein hydrolysates and emulsifying lipids.

The oat protein preparation was suspended in water (1:10) and the protein was enzymatically hydrolyzed using an Aspergillus niger microbial protease at neutral pH (1% of the protein content of the preparation of

25 oat protein). The enzyme was quenched by heating the reaction mixture to 90 ° C for 30 min. The mixture was centrifuged and the precipitate was lyophilized.

Example 4

The same oat fraction was used as in Example 2 (27% protein, 9% total lipids, including> 2% emulsifying lipids and 52% carbohydrates) for the preparation of a composition which contained hydrolysed proteins and emulsifying lipids.

The oat fraction was suspended in water (1:10) and treated first with α-amylase (Fungamyl 800L,

35 Novozymes, 1% of the starting material, 65ºC, 1 hour) to partially hydrolyze the starch and then with cellulase and β-glucanase at 55ºC for 2 hours (GC440, Genencor and Ultraflo L, Novozymes, both 2% of the material starting) to hydrolyze the fiber components. The resulting mixture was then hydrolyzed at 37 ° C with pepsin (Sigma, pH 2, 8 hours, 1% of the protein content of the starting material) and with pancreatin (Sigma, pH 8, 8 hours, 1% of the protein content of the starting material). Enzymes were inactivated by heating the mixture of

40 reaction at 90 ° C for 30 min. The mixture containing protein hydrolyzate and emulsifying lipids as such was lyophilized.

Example 5

A therapeutic composition comprising an oatmeal fraction comprising protein and emulsifying lipids was prepared from whole grain oat material (average composition of 13% protein, 7% total lipids, 67% carbohydrates). carbon). The whole grain starting material was enzymatically processed in two phases to obtain a composition comprising protein and emulsifying lipids. First, an oatmeal material containing 29% protein, 10% total lipids, including at least the

50 2.5% emulsifying lipids (dry weight).

This material was further processed with an increased protein content: the oat material was suspended in water and heated to 90 ° C to gelatinize the starch. A thermostable α-amylase (Spezyme FRED, Genencor, 1% of the starting material) was added to the reaction vessel and allowed to react for 2

55 hours to reduce starch content. The reaction mixture was then cooled to 65 ° C and treated with enzymes that hydrolyze cellulose and β-glucan at 65-55 ° C (GC440, Genencor and Ultraflo L, Novozymes, both 2% of the starting material) at neutral pH for 2 hours , after which the precipitate was separated by a separator and lyophilized. The composition contained 46% protein, 12% total lipids, including> 3% emulsifying lipids.

Example 6

A fraction rich in oat bran was used as a starting material for the preparation of a composition containing protein hydrolysates and emulsifying lipids. The starting material contained 17% protein, 8%

65 lipids (including> 2% emulsifying lipids), 17% fiber and 46% other carbohydrates.

The fraction rich in oat bran was mixed with water (1:10) and heated to 90 ° C to gelatinize the starch. A thermostable α-amylase (Spezyme FRED, Genencor, 1% of the starting material) was added to the reaction vessel and allowed to react for 2 hours at 90 ° C to reduce the starch content. The reaction mixture was treated with enzymes that hydrolyze cellulose and β-glucan at 65-55 ° C (GC440, Genencor and Ultraflo L, Novozymes, both 2% of the starting material) at neutral pH for 5 hours to hydrolyze the components of fiber. The fiber content of the oat bran-rich fraction was greater than that of the fractions used in other examples and therefore an extended hydrolysis time with cellulase and β-glucanase was also used. The resulting mixture was then hydrolyzed at 37 ° C with pepsin (Sigma, pH 2, 8 hours, 1% of the protein content of the material

10 starting). The reaction mixture was neutralized and heated to 90 ° C for 30 min. to inactivate the enzyme. The precipitate was separated by centrifugation and lyophilized.

Example 7

15 In vitro activity test

The compositions of examples 1 and 2 were compared with a commercial hypocholesterolemic agent, CSPHP soy protein phospholipid hydrolyzate complex (Kyowa Hakko). It is known that commercial CSPHP hypocholesterolemic agent binds taurocholate bile acid in vitro and increases acid excretion

20 faecal bile in rats. This agent reduces LDL-cholesterol and total serum cholesterol in humans and in rats. It is known that bile acid binding and increased fecal bile acid excretion is one of the mechanisms that many hypocholesterolemic components use.

The bile acid binding capacity of the compositions of Examples 1 and 2 was compared with the capacity

Bile acid binding of CSPHP in an in vitro test. Weigh from 100 mg to 1000 mg of test material (CSPHP, the composition of example 1 or the composition of example 2) and mixed with a known amount of colic acid (approximately 10 mM) in phosphate buffer (pH 7.4 ) and stirred overnight. The supernatant was removed by centrifugation. The concentration of colic acid in the supernatant (unbound colic acid) was measured by gas chromatography with an external standard method. The amount was calculated

30 of the colic acid bound to the test material from the amount of unbound colic acid and the amount of total colic acid was used in the test. The amount of bound colic acid (mg) per g of test material was calculated as an average value of two duplicate analyzes.

Table 1. Results of the in vitro activity test

Mg of bound colic acid / g of test material

Composition of Example 1

21.8

Composition of Example 2

24.4

CSPHP commercial agent

19.6

The results shown in Table 1 indicate that the compositions of the present invention worked in a similar or even better way in testing a commercial hypocholesterolemic agent CSPHP that is known to lower serum levels of LDL-cholesterol and total cholesterol. The oat-based compositions of the present invention bound 11-25% more colic acid than the commercial hypocholesterolemic agent, which

40 indicates the potential of oat-based compositions of the present invention as components for improving serum lipid profile.

Example 8

45 Animal testing

The effect of improving the lipid profile of compositions containing an oatmeal fraction comprising protein and emulsifying lipids (composition of example 5 = composition C) and an oat fraction comprising hydrolyzing of oat proteins and emulsifying lipids ( composition of example 2 =

Composition B) using female mice deficient in the LDL receptor as test animals.

The objective of the test was to study the effect of reducing serum triglycerides and total cholesterol that could be obtained using the compositions of the present invention as part of an atherogenic diet (containing 0.25% by weight of cholesterol and 18% in cocoa butter weight).

55 The animals were assigned to 3 groups (n = 8 in each group) and fed with experimental diets for 4 weeks, after which changes in triglycerides and serum cholesterol were measured.

It was used as a basic diet Clinton / Cybulsky (D12106p, without protein), from Research Diets Inc.

All experimental diets were formulated to contain 20% protein as N equivalents. In the control group (group A) the only source of protein was casein (88% purity). In the test groups (B and C) the protein source was half casein and half (as N equivalents) of composition B or composition C. Otherwise, the diets had the same composition.

Table 2. Experimental results

Group A control

Group B composition B (example 2) Group C composition C (example 5)

Total serum cholesterol (mmol / l), average

18.7 14.6 16.8

Change (%) compared to control group

-22.1 -10.4

Serum triglycerides (mmol / l), mean

3.7 2.7 3.0

Change (%) compared to control group

-26.2 -18.5

As shown in Table 2, both compositions of example 2 (group B) and example 5 (group C) had

10 an effect of lowering serum cholesterol and lowering serum triglycerides compared to the control group containing casein as the sole source of protein. The results were surprising, especially since half of the source of N fed was inactive casein. Especially serum triglycerides were decreased surprisingly well in groups B and C.

15 Example 9

Cereal product similar to yogurt

The oatmeal composition of Example 1 was used in a cereal product preparation similar to fermented yogurt.

Oat milk 72.0% Strawberry Jam 20.0% Composition of Example 1 5.0% 2.5% oat bran 0.5% pectin

Yogurt was prepared by conventional yogurt preparation methods and fermented with Bifidobacteria culture. A 150 g portion of the product contained 7.5 g of the composition of example 1.

25 Example 10

Food bar

The composition of Example 3 was used for the preparation of food bars.

oat flakes 32.0% oat bran 8.0% corn syrup 15.0% brown sugar 5.0% 5.5% concentrated apple juice 2.0% apple grape passes 3.0% vegetable fat 12.0% 0.5% salt flavoring 0.5% composition of example 3 16%

0.5% lecithin

A 45 g food stick contained 7.2 g of the composition of example 3.

Example 11

5 Product similar to yogurt

75.5% soy milk Strawberry Jam 20.0% Composition of Example 4 4.0% 0.5% pectin

Yogurt was prepared by conventional soy yogurt preparation methods and fermented with 10 Bifidobacteria culture. A 150 g portion of the product contained 6.0 g of the composition of example 4.

Example 12

Flour mix for cookie preparation

15 Sugar 19.0% Wheat flour 37.5% Composition of example 6 15.3% Salt 0.5% Vanilla aroma 0.2% Sodium bicarbonate 0.5% Chocolate pieces 27.0%

Butter (34% of the flour mixture), eggs (10% of the flour mixture) and water (16% of the flour mixture) are added to the flour mixture when the cookies are prepared. The cookies are baked at 180 ° C for 810 min. A portion of two cookies (24 g) contains 2.4 g of the composition of example 6.

Example 13

Wheat pasta

Soft wheat flour 45.0% Hard Wheat Flour 43.0% Composition of Example 2 12.0%

The pulp was produced using a conventional high temperature pulp procedure (Pavan Mapimpianti / Italy; Termo-Active-System). A 70 g portion contained 8.4 g of the composition of example 2.

Example 14

30 Meatballs

Minced meat, 17% fat 57.4% Water 14.2% Eggs 13.5% Onion (sliced) 7.0% Composition of Example 1 7.0% Salt 0.9%

The meatballs were prepared in an oven at 200 ° C. A 120 g portion contained 12.4 g of the composition of example 1.

Example 15

5 Vegetable Powder Soup

Dehydrated vegetables (tomatoes, onions, garlic) 33.0% Potato starch 18.0% Maltodextrin 4.3% Composition of Example 5 28.0% 6.0% partially hydrogenated soybean oil Sucrose 7.0% 3.0% salt 0.2% guar gum Species and aromas 0.5%

A 25 g portion contained 7 g of the composition of example 5. 10

Example 16

Cereal product similar to yogurt

The oatmeal composition of Example 1 and the ester of vegetable stanols were used in a preparation of fermented yogurt-like cereal product.

70.0% oat milk Strawberry Jam 20.0% Composition of Example 1 5.0% 2.5% oat bran 0.5% pectin Ester of vegetable stanols 2,0%

Yogurt was prepared by conventional yogurt preparation methods. A 150 g serving of the product

20 contained 7.5 g of the composition of example 1 and 3 g of vegetable stanol ester (1.8 g as sterol equivalents).

Claims (37)

1. A therapeutic composition for oral use comprising at least 25% dry weight of protein and at least 1% dry weight of emulsifying lipids, both protein and emulsifying lipids being obtained from 5 of the same oat fraction, and the weight ratio of protein with respect to emulsifying lipids is from 1: 0.01 to 1: 0.6, said β-glucan composition further comprising an amount of at most 8 % by dry weight, and in which the emulsifying lipids comprise phospholipids and glycolipids and the weight ratio of phospholipids to glycolipids is from 1: 0.7 to 1: 6.

2.

 The therapeutic composition according to claim 1, the composition being obtainable from an oat endosperm-rich fraction comprising at least 10% dry weight of protein and at least 1% dry weight of emulsifying lipids.

3.

 The therapeutic composition according to claim 1, the composition being obtainable from a fraction

Whole grain based oatmeal comprising at least 10% dry weight of protein and at least 1% dry weight of emulsifying lipids.

Four.

 The therapeutic composition according to claim 1, the composition can be obtained from a fraction rich in oat bran comprising at least 10% dry weight of protein and at least 1% dry weight of emulsifying lipids.

5.

 The therapeutic composition according to any one of claims 1 to 4, the composition comprising at least 30%, more preferably at least 35%, and most preferably at least 40% dry protein weight.

6.

 The therapeutic composition according to any one of claims 1 to 5, the composition comprising at least 2%, more preferably at least 3%, even more preferably at least 4%, even more preferably at least 5% and most preferably at least 6% dry weight of emulsifying lipids.

7.

 The therapeutic composition according to any one of claims 1 to 6, the composition comprising from 25 to 99%, preferably from 30 to 98%, more preferably from 35 to 97.5%, even more preferably from the 40 to 97% and most preferably from 40 to 94% dry protein weight.

The therapeutic composition according to claim 7, the composition comprising from 1 to 15%, preferably from 2 to 15%, more preferably from 2.5 to 15%, even more preferably from 3 to 15%, even more preferably from 4 to 15%, even more preferably from 5 to 15%, and most preferably from 6 to 15% by dry weight of emulsifying lipids. 9. The therapeutic composition according to any one of claims 1 to 6, the composition comprising from 25 to 98%, preferably from 30 to 98%, more preferably from 35 to 97.5%, even more preferably from 40 to 97% and most preferably from 40 to 94% by dry protein weight. 10. The therapeutic composition according to claim 9, the composition comprising from 2 to 15%, preferably from 2 to 10%, more preferably from 2.5 to 10%, even more preferably from 3 to 8%, even more preferably from 4 to 8%, even more preferably from 5 to 8% and most preferably from 6 to 8% by dry weight of emulsifying lipids.

eleven.

 The therapeutic composition according to any one of claims 1 to 10, further comprising dietary fiber in an amount of at most 15%, preferably at most 10%, more preferably at most 5% and most preferably at most 3 % dry weight.

12.

 The therapeutic composition according to any one of claims 1 to 11, which comprises β-glucan in

An amount of a maximum of 5%, preferably a maximum of 3% and more preferably a maximum of 2% by dry weight.

13.

 The therapeutic composition according to any one of claims 1 to 12, wherein the weight ratio of phospholipids to glycolipids is from 1: 1 to 1: 5, preferably from 1: 1 to 1: 3.

14.

 The therapeutic composition according to any one of claims 1 to 13, further comprising plant sterol.

fifteen.

 The therapeutic composition according to claim 14, wherein the weight ratio of vegetable sterol with

65 relative to protein is from 1: 0.02 to 1: 150, preferably from 1: 0.2 to 1:30, more preferably from 1: 0.4 to 1: 12.5 and most preferably from 1: 1 to 1: 5. 16. A therapeutic composition for oral use comprising at least 15% dry weight of protein hydrolyzate and at least 1% dry weight of emulsifying lipids, both protein and emulsifying lipids being obtained from the same fraction of oatmeal that has undergone hydrolysis, and the weight ratio of The protein hydrolyzate with respect to emulsifying lipids is from 1: 0.01 to 1: 1, said β-glucan composition further comprising an amount of at most 8% by dry weight, and in which the emulsifying lipids they comprise phospholipids and glycolipids and the weight ratio of phospholipids to glycolipids is from 1: 0.7 to 1: 6.

17.

 The therapeutic composition according to claim 16, the composition being obtainable by hydrolyzing an oat endosperm-rich fraction comprising at least 10% dry weight of protein and at least 1% dry weight of emulsifying lipids.

18.

 The therapeutic composition according to claim 16, the composition being obtainable by hydrolyzing a

15 oat fraction based on whole grain comprising at least 10% dry weight of protein and at least 1% dry weight of emulsifying lipids.

19.

 The therapeutic composition according to claim 16, the composition being obtainable by hydrolyzing a fraction rich in oat bran comprising at least 10% dry weight of protein and at least 1% dry weight of emulsifying lipids.

twenty.

 The therapeutic composition according to any one of claims 16 to 19, the composition comprising at least 20%, preferably at least 30% by dry weight of protein hydrolyzate.

21. The therapeutic composition according to any one of claims 16 to 20, the composition comprising at least 2%, preferably at least 3%, more preferably at least 4%, even more preferably at least 5% and more preferably at least 6% dry weight of emulsifying lipids.

22

 The therapeutic composition according to any one of claims 16 to 21, wherein the weight ratio of phospholipids to glycolipids is from 1: 1 to 1: 5, preferably from 1: 1 to 1: 3.

2. 3.

 The therapeutic composition according to any one of claims 16 to 22, wherein the composition further comprises dietary fiber in an amount of at most 15%, preferably at most 10%, more preferably at most 5% and most preferably maximum 3% dry weight.

24.

 The therapeutic composition according to any one of claims 16 to 23, comprising β-glucan in an amount of at most 5%, preferably at most 3% and more preferably at most 2% by dry weight.

25.

 The therapeutic composition according to any one of claims 16 to 24, wherein the amount of protein hydrolyzate is from 15 to 99%, preferably from 20 to 98%, more preferably from 30 to 97% and most preferably from 30 to 94% by dry weight.

26.

 The therapeutic composition according to claim 25, wherein the amount of emulsifying lipids is of

From 1 to 15%, preferably from 2 to 15%, more preferably from 2.5 to 15%, even more preferably from 3 to 15%, even more preferably from 4 to 15 %, even more preferably from 5 to 15%, and most preferably from 6 to 15% by dry weight.

27.

 The therapeutic composition according to any one of claims 16 to 24, wherein the amount of protein hydrolyzate is from 15 to 98%, preferably from 20 to 98%, more preferably from 30 to 97% and most preferably from 30 to 94% by dry weight.

28.

 The therapeutic composition according to claim 27, wherein the amount of emulsifying lipids is from 2 to 15%, preferably from 2 to 10% by dry weight, more preferably from 2.5

55 to 10%, even more preferably from 3 to 8%, even more preferably from 4 to 8%, even more preferably from 5 to 8% and most preferably from 6 to 8% dry weight

29.

 The therapeutic composition according to any one of claims 16 to 28, wherein the protein hydrolyzate comprises resistant protein.

30

 The therapeutic composition according to any one of claims 16 to 29, wherein the protein hydrolyzate has a molecular weight of 300-100,000 D, preferably 500-50,000 D, more preferably 500

30,000 D, even more preferably 900-30,000 D and most preferably 1,600-30,000 D. 65 31. The therapeutic composition according to any one of claims 16 to 30, wherein the degree of hydrolysis of the protein is from 1 to 40%, preferably from 3 to 30% and most preferably from 5 up to 20% 32. The therapeutic composition according to any one of claims 16 to 31, further comprising 5 plant sterol. 33. The therapeutic composition according to claim 32, wherein the weight ratio of vegetable sterol to protein is from 1: 0.02 to 1: 150, preferably from 1: 0.2 to 1:30, more preferably from 1: 0.4 to 1: 12.5 and most preferably from 1: 1 to 1: 5. 34. A food product comprising at least one basic nutritional component and a therapeutic composition according to any one of claims 1 to 33. 35. Use of a composition comprising according to any one of claims 1 to 33, for the manufacture of a pharmaceutical or nutraceutical or food product to improve the serum lipid profile. 36. A method for preparing a therapeutic composition according to any one of claims 1 to 15, said method comprising treating an oatmeal fraction comprising both protein and emulsifying lipids and carbohydrates to remove carbohydrates, preferably by hydrolysis 20 enzymatic, and to obtain said therapeutic composition having an increased protein content. 37. A method of preparing a therapeutic composition according to any one of claims 16 to 33, said method comprising hydrolyzing an oat fraction comprising both protein and emulsifying lipids to obtain said therapeutic composition. 38. The method according to claim 37, wherein the degree of hydrolysis is from 1 to 40%, preferably from 3 to 30% and most preferably from 5 to 20%. 39. The method according to claim 37 or 38, wherein the oat fraction is hydrolyzed by enzymatic hydrolysis, preferably using a protease.